Method for Providing Rotation Stops and Detents for Wheels in Medical Devices - Patent application

Abstract

A blood collection device for delivering a probe into a patient's vasculature, the blood collection device including a housing having a proximal end and a distal end, and an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel, the blood collection device also including an advancement stop positionable by a user via an interface portion exterior to the housing and configured to selectively limit rotation of the advancement wheel.

Description

[Technical field]

[0001] The present disclosure relates generally to blood collection devices and associated assemblies, systems, and methods for use with catheters, such as peripheral intravenous catheters (PIVCs), for example. More specifically, the blood collection device is a wheel-based instrument configured to include an adjustable advancement stop for indwelling catheters of various lengths. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 332,513, entitled "Method of Providing Stops and Detents for the Rotation of a Wheel in a Medical Device," filed April 19, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse saline, various medications, or total parenteral nutrition. Additionally, catheters may also be used to withdraw blood from a patient.

[0004] The catheter may be an over-the-needle peripheral intravenous catheter (PIVC). In this case, the catheter may be mounted over an introducer needle with a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle points away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature. After properly placing the needle, the clinician may temporarily occlude flow in the vasculature, remove the needle, and leave the catheter in place (i.e., "indwell") for future blood withdrawal and / or fluid injection.

[0005] To complete blood collection from a PIVC with an indwelling catheter, blood collection devices have been developed that are configured to overcome previous challenges associated with blood collection via a PIVC, such as, for example, potential catheter collapse, reduced blood flow due to debris accumulated on or within the catheter, etc. Examples of such devices are shown and described in U.S. Patent Application Publication No. 2021 / 0290905A1, which is incorporated herein by reference in its entirety. The blood collection device shown and described in U.S. Patent Application Publication No. 2021 / 0290905A1 includes an elongated probe (e.g., a nickel titanium wire) that may be releasably coupleable to the PIVC and selectively advanceable distally through the catheter, the probe providing a fluid channel to enable blood collection into the blood collection device. Advancement and retraction of the probe is controlled by a rotatable wheel within the housing of the blood collection device, which allows the clinician to use his or her thumb to rotate the wheel in a first direction to advance the probe and rotate it in a second, opposite direction to retract the probe.

[0006] More recently, wheel-based blood collection devices have been provided with physical stop configurations to define the fully advanced and fully retracted positions of the probe while still allowing more than a full 360° rotation of the wheel. An example of such a device is provided in U.S. Patent Application Serial No. 17 / 570,566, which is incorporated herein by reference in its entirety. FIGS. 1A-1D show a blood collection device 10 similar to that shown and described in some embodiments of U.S. Patent Application Serial No. 17 / 570,566. The blood collection device 10 includes a housing 12, an advancement wheel 14, and a second wheel 18, the advancement wheel 14 and the second wheel 18 configured to rotate about a common axis of rotation 16. Although not shown, the housing 12 includes a distal end and a proximal end, the distal end configured to couple to a PIVC and the proximal end configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 14 to allow selective advancement and retraction of the probe from the housing 12.

[0007] The inner surface of the housing 12 includes a housing stop member 20, which may include a protrusion. Additionally, the inner surface of the advancement wheel 14 includes a wheel stop member 24, which may also include a protrusion. In some embodiments, a gap exists between the housing stop member 20 and the wheel stop member 24 such that the housing stop member 20 and the wheel stop member 24 do not contact each other during rotation of the advancement wheel 14. However, the second wheel 18 may be configured to fill the gap between the housing stop member 20 and the wheel stop member 24, thereby including a tab 22 that limits the rotation of the advancement wheel 14 at two separate positions, one associated with maximum advancement of the probe out of the housing 12 and the other associated with maximum retraction of the probe into the housing 12.

[0008] With reference to FIG. 1A, the blood collection device 10 is shown in a first configuration, with the probe (not shown) in a fully retracted position, as the advancement wheel 14 cannot rotate further in the retraction direction 28 due to the interaction between the housing stop member 20, the tab 22, and the wheel stop member 24. However, as shown in FIG. 1B, the advancement wheel 14 can be rotated in the forward direction 26, thereby advancing the probe out of the housing 12 and into the PIVC. After about one rotation of the advancement wheel 14, the wheel stop member 24 contacts the upper surface of the tab 22 of the second wheel 18, as shown in FIG. 1C, allowing co-rotation of both the advancement wheel 14 and the second wheel 18. Now, with reference to FIG. 1D, after approximately an additional full rotation of the advancement wheel 14, the tab 22 contacts the upper surface of the housing stop member 20, thereby preventing further rotation of the advancement wheel 14 in the forward direction 26, which provides a physical stop to further advancement of the probe out of the housing 12. In this manner, the advancement wheel 14 is configured for multiple revolutions, thereby allowing sufficient advancement and retraction of the probe, but a physical stop is provided to avoid undesirable over-advancement or over-retraction of the probe.

[0009] However, in some instances, the PIVC is provided with a variable length indwelling catheter, where a particular length is selected based on, for example, the patient's anatomy, application, etc. For example, Becton Dickinson's BD NEXIVA™ Closed IV Catheter System provides a 20 gauge PIVC with catheter lengths of 1.00 inches, 1.25 inches, and 1.75 inches, respectively. While these catheters with various lengths may allow for improved placement of the PIVC within the patient's vasculature, they may prove problematic when used with a fluid transfer device configured to draw blood via the PIVC. Specifically, the probe of the blood drawing device typically has a maximum extension length that may be advanced beyond the distal tip of the indwelling catheter. That maximum length of the probe may be sufficient for adequate projection from a PIVC with a shorter catheter length, for example, 1.00 inches, but may not provide sufficient projection from a PIVC with a longer catheter length, for example, 1.75 inches. Conversely, if a blood collection device is designed to provide adequate projection from a PIVC with a longer catheter length (e.g., 1.75 inches), the probe of that same device may extend an undesirable distance beyond the tip of a shorter (e.g., 1.00 inch) catheter, and the user may not receive an indication of how far the probe extends beyond the distal tip of the catheter. Summary of the Invention

[0010] Accordingly, the present disclosure relates generally to a blood collection device, and associated assemblies, systems, and methods, for use in drawing blood via an indwelling catheter, the blood collection device including a forward stop selectively positioned by a user to cause a length of a probe extending from the blood collection device to be compatible with an indwelling catheter of variable length.

[0011] In accordance with an embodiment of the present disclosure, a blood collection device for delivering a probe to a patient's vasculature is disclosed, the blood collection device including a housing having a proximal end and a distal end, an advancement wheel operably coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel, and an advancement stop member positionable by a user via an exterior interface portion of the housing and configured to selectively limit rotation of the advancement wheel.

[0012] In some embodiments, the blood collection device further includes a second wheel, the second wheel configured to rotate with the advancement wheel about a common axis of rotation.

[0013] In some embodiments, the housing further includes a housing stop member, the advancement wheel includes a wheel stop member, and the second wheel includes the tab.

[0014] In some embodiments, the tabs of the second wheel are configured to selectively fill a gap between the housing stop member and the wheel stop member.

[0015] In some embodiments, the forward stop member includes a protrusion, and the tab of the second wheel is configured to selectively fill a gap between the protrusion and the wheel stop member.

[0016] In some embodiments, the advancement stop member is movable within a slot formed in the housing to selectively position the protrusion against the tab of the second wheel.

[0017] In some embodiments, the slot is a vertical slot formed in the housing.

[0018] In some embodiments, the slot is an arcuate slot formed in the housing.

[0019] In some embodiments, the housing includes indicia adjacent the slot, the indicia relating to various catheter lengths of intravenous catheters that can be used with the blood collection device.

[0020] In some embodiments, the advancement stop member is selectively movable within the housing via a push button interface.

[0021] In some embodiments, the advancement stop member is selectively insertable and removable from the housing.

[0022] In some embodiments, the housing further includes a ramp and detent portion adjacent the housing stop member.

[0023] In some embodiments, the tab includes a central slit.

[0024] According to another aspect of the present disclosure, a blood collection device for delivering a probe into a patient's vasculature is disclosed, the blood collection device including a housing having a proximal end and a distal end, an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel, and further, the advancement wheel selectively positionable within the housing for varying an effective length of the probe based on a position of the advancement wheel.

[0025] In some embodiments, the axis of rotation of the advancement wheel is configured to move within a longitudinal slot formed in the housing.

[0026] In some embodiments, the advancement wheel is positionable between at least a first position and a second position, the first position associated with a first catheter length of an intravenous catheter usable with the blood collection device, and the second position associated with a second catheter length of an intravenous catheter usable with the blood collection device.

[0027] According to another aspect of the present disclosure, a blood collection device for delivering a probe into a patient's vasculature is disclosed, the blood collection device including a housing having a proximal end and a distal end, and an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel. The blood collection device also includes a rotatable spool configured to hold at least a portion of the probe, the rotatable spool including a probe anchor, and an amount of rotation of the rotatable spool selectively limitable to vary an effective length of the probe based on the amount of rotation of the rotatable spool.

[0028] In some embodiments, the blood collection device also includes a rotatable knob accessible to a user from outside the housing.

[0029] In some embodiments, the rotatable knob is operably coupled to a spool stop member that extends into the housing.

[0030] In some embodiments, the blood collection device further includes a housing stop member, the spool stop member configured to contact the housing stop member to limit rotation of the rotatable spool and provide adjustment of the effective length of the probe.

[0031] Further details and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals throughout. [Brief description of the drawings]

[0032] [Figure 1A] FIG. 1 is a partial cross-sectional view of a prior art blood collection device in a first configuration. [Figure 1B] 1B is a partial cross-sectional view of the prior art blood collection device of FIG. 1A in a second configuration. [Figure 1C] FIG. 1B is a partial cross-sectional view of the prior art blood collection device of FIG. 1A in a third configuration. [Figure 1D]FIG. 1B is a partial cross-sectional view of the prior art blood collection device of FIG. 1A in a fourth configuration. [Diagram 2] FIG. 1 is a partial cross-sectional view of a blood collection device according to an embodiment of the present disclosure in a first configuration. [Diagram 3] 3 is a partial cross-sectional view of the blood collection device of FIG. 2 in a second configuration. [Figure 4] FIG. 3 is a partial rear perspective view of the blood collection device of FIG. 2. [Diagram 5] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 6] FIG. 6 is a rear view of the blood collection device of FIG. 5. [Figure 7] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 8] FIG. 8 is a partial rear view of the blood collection device of FIG. 7. [Figure 9] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 10] 10 is a partial cross-sectional view of the housing of the blood collection device of FIG. 9. [Figure 11] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 12] 12 is another partial cross-sectional view of the blood collection device of FIG. 11. [Figure 13] FIG. 13 is a partial cross-sectional end view of a blood collection device according to another aspect of the present disclosure. [Figure 14] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 15] 1 is a partial cross-sectional view of a blood collection device according to another aspect of the present disclosure. [Figure 16] FIG. 16 is a partial rear view of the blood collection device of FIG. 15. [Figure 17] FIG. 13 is a partial rear view of a blood collection device according to another aspect of the present disclosure. [Figure 18] FIG. 18 is a partial internal view of the blood collection device of FIG. 17 in a first configuration. [Figure 19] FIG. 18 is a partial internal view of the blood collection device of FIG. 17 in a second configuration. [Figure 20]FIG. 18 is a partial internal view of the blood collection device of FIG. 17 in a third configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0034] For purposes of explanation hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered as limiting.

[0035] In this disclosure, a distal end of a component or device means the end furthest from a user's hand, and a proximal end means the end closest to the user's hand when the component or device is in the use position, i.e., when a user is holding the fluid transfer device during preparation or use. Similarly, in this application, the terms "distally" and "distally" mean the direction toward the connector portion of the fluid transfer device, and the terms "proximally" and "proximally" mean the direction opposite to the direction of the connector.

[0036] Although not shown or described herein, it should be understood that the blood collection devices described below may be utilized to collect blood from any suitable vascular access device, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or another suitable vascular access device.

[0037] Embodiments of the present disclosure are described primarily in the context of a fluid transfer device for use with a PIVC, however, embodiments of the present disclosure extend equally to use with other catheter devices.

[0038] 2-4, a blood collection device 50 according to an embodiment of the present disclosure is shown. Similar to the blood collection device 10 described above with respect to FIGS. 1A-1D, the blood collection device 50 includes a housing 52, an advancement wheel 54, and a second wheel 58, the advancement wheel 54 and the second wheel 58 configured to rotate about a common axis of rotation 56. The housing 52 includes a distal end and a proximal end, the distal end configured to couple to a PIVC, and the proximal end configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 54 to enable selective advancement and retraction of the probe from the housing 52. The probe (e.g., a nickel titanium wire) may be selectively advanced distally through the PIVC, the probe providing a fluid channel to enable blood collection to a blood collection device coupled to the blood collection device 50. Alternatively, it should be understood that the probes described herein may be any suitable guidewire, tube, secondary catheter, instrument, occluder, rod, wire having fluid paths and / or sensors, or any other flexible member that can be advanced through a catheter.

[0039] The inner surface of the housing 52 includes a housing stop member 60, while the inner surface of the advancement wheel 54 includes a wheel stop member 64. Although not visible in Figures 2-3, it should be understood that a gap exists between the housing stop member 60 and the wheel stop member 64 such that the housing stop member 60 and the wheel stop member 64 do not come into contact during rotation of the advancement wheel 54. However, the second wheel 58 includes a tab 62 configured to fill the gap between the housing stop member 60 and the wheel stop member 64, thereby limiting rotation of the advancement wheel 54 at a maximum forward position of the probe out of the housing 52 when rotated in a forward direction 70, and conversely, limiting maximum retraction of the probe into the housing 52 when rotated in a retraction direction 72.

[0040] As noted above, the indwelling catheter to which the blood collection device is fluidly coupled may have a variety of lengths and / or gauges, with the particular length and / or gauge being selected based on, for example, the patient's anatomy, application, location, etc. For example, the catheter may have a length of 0.5 inches, 0.75 inches, 1.0 inches, 1.25 inches, 1.5 inches, or 1.75 inches. However, it should be understood that these lengths are not limiting and the catheter may be longer or shorter. Additionally, the catheter may have a variety of gauges, such as, for example, 18G, 20G, 22G, or 24G. However, as with the catheter length, the catheter may have any suitable gauge and is not limited to the above examples.

[0041] 2-4, blood collection device 50 further includes a advancement stop member 66. In the embodiment shown in FIGS. 2-4, advancement stop member 66 is linearly movable along a slot 76 formed in housing 52 of blood collection device 50. Advancement stop member 66 includes an interface portion 74 that extends outside of housing 52, which provides a user with an interface for selectively engaging or disengaging advancement stop member 66. A protrusion 68 is provided on the top of advancement stop member 66 and protrudes into housing 52.

[0042] Similar to the housing stop member 60, a gap exists between the protrusion 68 of the advancement stop member 66 and the wheel stop member 64 such that the protrusion 68 and the wheel stop member 64 do not contact each other during rotation of the advancement wheel 54. However, the tab 62 of the second wheel 58 is configured to fill the gap between the protrusion 68 and the wheel stop member 64, thereby selectively limiting the rotation of the advancement wheel 54 when the advancement stop member 66 is in a particular position. For example, in the configuration shown in FIG. 2, the advancement stop member 66 is in a first (or "disengaged") position and the protrusion 68 is disposed over and does not contact the tab 62 when the second wheel 58 is rotated by the advancement wheel 54. In this manner, the advancement wheel 54 can rotate fully, limited only by the interaction between the housing stop member 60 and the tab 62. Thus, the configuration shown in FIG. 2 may be selected by a user when the PIVC catheter is of a longer known length (e.g., 1.75 in.) since the minimal restriction of the advancement wheel 54 allows for maximum advancement of the probe through the catheter.

[0043] 3 and 4, however, a user may selectively actuate advancement stop member 66 (via interface portion 74 along slot 76) such that protrusion 68 is disposed within the arc of travel of tab 62, thereby creating a physical stop for second wheel 68 and advancement wheel 54 prior to reaching housing stop member 60, limiting the rotation of advancement wheel 54 and therefore linear advancement of the probe through the PIVC. Thus, a user may actuate advancement stop member 66 in such a manner if the catheter of the PIVC has a shorter known length (e.g., 1.0 inch) since the advancement distance of the probe beyond the distal end of housing 52 is limited. In some embodiments, advancement stop member 66 is manually set by a user prior to connecting blood collection device 50 to the PIVC.

[0044] 2-4, the advancement stop member 66 is shown as being slidable along a slot 76 on the housing 52 to control engagement / disengagement, it is understood that the device is not so limited. For example, the advancement stop member 66 may be configured as a removable member that can be selectively inserted into an opening in the housing 52 in a pin-like manner to provide a supplemental physical stop to a full rotation of the advancement wheel 54. Additionally, while only one advancement stop member 66 is shown in FIGS. 2 and 4, it is understood that in other embodiments, two or more advancement stop members may be provided along the housing 52. In this manner, the blood collection device 50 may be used in conjunction with catheters having other intermediate lengths (e.g., 1.0 inch, 1.25 inch, 1.5 inch, 1.75 inch, etc.), and a user may selectively actuate an advancement stop member associated with a known catheter length to direct movement of the probe from the housing.

[0045] 5 and 6, a blood collection device 80 according to another embodiment of the disclosure is shown. The blood collection device 80 includes a housing 82 and an advancement wheel 84 configured to rotate about an axis of rotation 88. The blood collection device 80 includes a distal end portion 86 and a proximal end portion 87, where the distal end portion 86 is configured to couple to a PIVC, for example, via an alligator clip connector, and the proximal end portion 87 is configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 84 to enable selective advancement and retraction of the probe from the housing 82. The probe (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire with a fluid path and / or a sensor, etc.) can be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 80.

[0046] An inner surface of the housing 82 includes a housing stop member 94, and an inner surface of the advancement wheel 84 includes a wheel stop member 92. In some embodiments, the housing stop member 94 is configured to limit rotation of the advancement wheel 94 at a maximum advancement position of the probe out of the housing 82 when rotated in a first (advance) direction, and conversely, to limit a maximum retraction of the probe into the housing 82 when rotated in a second (retract) direction.

[0047] With further reference to Figures 5 and 6, blood collection device 80 further includes a advancement stop member 96. In the embodiment depicted in Figures 5 and 6, advancement stop member 96 is a push button style member that is laterally translatable within housing 82, as shown in Figures 5 and 6. Advancement stop member 96 includes an interface portion 97 that extends outside of housing 82, which provides a user with an interface for selectively engaging or disengaging advancement stop member 96. In some embodiments, advancement stop member 96 is configured as a click-type spring biased button.

[0048] When the advancement stop member 96 is in a first (or "disengaged") position, it is positioned within the housing 82 such that as the advancement wheel 84 rotates, it does not contact the wheel stop member 92. In this manner, the advancement wheel 84 can rotate fully, limited only by the interaction between the housing stop member 94 and the wheel stop member 92. This "disengaged" position of the advancement stop member 96 may therefore be selected by the user when the PIVC catheter is of a longer known length (e.g., 1.75 inches) because the minimal restriction of the advancement wheel 84 allows maximum advancement of the probe through the catheter.

[0049] However, a user may selectively actuate the advancement stop member 96 such that the advancement stop member 96 is disposed within the arc of travel of the wheel stop member 92, thereby forming a physical stop of the advancement wheel 84 prior to reaching the housing stop member 94, limiting the rotation of the advancement wheel 84 and therefore the linear advancement of the probe through the PIVC. Thus, a user may actuate the advancement stop member 96 in such a manner where the catheter of the PIVC has a shorter known length (e.g., 1.0 inch) as the advancement distance of the probe beyond the distal end of the housing 82 is limited. Although only a single advancement stop member 96 is shown in FIGS. 5 and 6, it will be understood with reference to FIGS. 5 and 6 that two or more advancement stop members may be provided, with each advancement stop member associated with a different catheter length available in the blood collection device 80.

[0050] Although the advancement stop member 96 has been described above as being a push button member that extends laterally inwardly into the housing 82, in other embodiments, the advancement stop member 96 may be configured to selectively extend longitudinally inwardly into the housing 82 and be selectively actuated via a rotation knob accessible at a distal or proximal end portion of the housing 82, for example.

[0051] 7 and 8, a blood collection device 100 according to another embodiment of the present disclosure is shown. The blood collection device 100 includes a housing 102, an advancement wheel 104, and a second wheel 106, the advancement wheel 104 and the second wheel 106 configured to rotate about a common axis of rotation. Although not shown, it should be understood that the housing 102 includes a distal end and a proximal end, the distal end configured to couple to a PIVC and the proximal end configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 104 to enable selective advancement and retraction of the probe from the housing 102. The probe (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire with a fluid path and / or a sensor, etc.) may be selectively advanced distally through the PIVC, providing a fluid channel to enable blood collection to a blood collection device coupled to the blood collection device 100.

[0052] The inner surface of the forward movement wheel 104 includes a wheel stop member 110, while the second wheel 106 includes a tab 108 configured to selectively contact the wheel stop member 110 to enable co-rotation between the forward movement wheel 104 and the second wheel 106.

[0053] Blood collection device 100 further includes an advancement stop member 112 that protrudes into housing 102. In the embodiment shown in Figures 7 and 8, with reference to Figures 7 and 8, advancement stop member 112 is selectively movable along an arc slot 114 formed in housing 102 of blood collection device 100. Advancement stop member 112 includes an interface portion 113 that extends outside of housing 102, which provides a user with an interface for selectively positioning advancement stop member 112 along arc slot 114.

[0054] Similar to the housing stop member 60 described above with respect to FIGS. 2-4, a gap exists between the advancement stop member 112 and the wheel stop member 110 such that the advancement stop member 112 and the wheel stop member 110 do not contact during rotation of the advancement wheel 104. However, the tab 108 of the second wheel 106 is configured to fill the gap between the advancement stop member 112 and the wheel stop member 110, thereby selectively limiting the rotation of the advancement wheel 104 when the advancement stop member 112 is in a particular position. For example, in the configuration shown in FIGS. 7 and 8, the advancement stop member 112 is in a first position, with the advancement stop member 112 disposed at its distal-most point within the slot 114. In this manner, the advancement wheel 104 can rotate to extend the maximum linear distance of the probe, with the rotation of the advancement wheel 104 limited by eventual contact between the advancement stop member 112 and the tab 108. Thus, the configuration shown in Figures 7 and 8 may be selected by the user when the PIVC catheter is of a longer known length (e.g., 1.75 inches) because minimal restriction of the advancement wheels 104 allows maximum advancement of the probe through the catheter.

[0055] However, in other scenarios, a user may selectively position the advancement stop member 112 so that rotation of the advancement wheel 104 is more restricted, thereby limiting linear advancement of the probe through the PIVC. A user may position the advancement stop member 112 in such a manner when the catheter of the PIVC has a shorter known length (e.g., 1.0 inch) since the advancement distance of the probe beyond the distal end of the housing 102 is limited. In some embodiments, the housing 102 may provide indicia 116 on its surface to assist the user in identifying the proper position of the advancement stop member 112 based on the known catheter length. Additionally and / or alternatively, in some embodiments, the slot 114 may include detents and / or increased interference fit at positions among the catheter length positions to aid in positioning of the advancement stop member 112.

[0056] 7 and 8 includes arc slots 114, it should be understood that the slots 114 may be configured in any suitable manner, such as, for example, vertically oriented straight slots, horizontally oriented straight slots, etc.

[0057] 9 and 10, a blood collection device 140 according to another embodiment of the present disclosure is shown. The blood collection device 140 includes a housing 142, an advancement wheel 144, and a second wheel 146, the advancement wheel 144 and the second wheel 146 configured to rotate about a common axis of rotation. It should be understood that a distal end of the housing 142 is configured to couple to a PIVC, and a proximal end of the housing 142 is configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 144 to enable selective advancement and retraction of the probe from the housing 142. The probe (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire with a fluid path and / or a sensor, etc.) can be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 140.

[0058] An inner surface of the advancement wheel 144 includes a wheel stop member 150, and the second wheel 146 includes a tab 148 configured to selectively contact the wheel stop member 150 to allow co-rotation between the advancement wheel 154 and the second wheel 156. The blood collection device 140 further includes an advancement stop member 154, which protrudes into the housing 142. In the embodiment shown in FIG. 10, the advancement stop member 154 is pivotable about an axis such that a distal end portion of the advancement stop member 154 moves along an arc slot 152 formed in the housing 142. Although not shown, it should be understood that the advancement stop member 154 includes an interface portion that extends outside the housing 142, which provides a user with an interface for selectively positioning the advancement stop member 154 along the arc slot 152. In some embodiments, the advancement stop member 154 can be, for example, a rotatable knob, a dial, or the like.

[0059] Depending on the position of the advancement stop member 154, the rotation of the advancement wheel 144 can be limited to correspondingly limit the linear movement of the probe. Thus, a user can select the position of the advancement stop member 154 based on the known length of the PIVC catheter.

[0060] 11 and 12, a blood collection device 160 according to another embodiment of the disclosure is shown. The blood collection device 160 includes a housing 162, an advancement wheel 164, and a second wheel 166, the advancement wheel 164 and the second wheel 166 configured to rotate about a common axis of rotation. The housing 162 includes a distal end and a proximal end, the distal end configured to couple to a PIVC and the proximal end configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 164 to enable selective advancement and retraction of the probe from the housing 162. The probe (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire having a fluid path and / or a sensor, etc.) may be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 160.

[0061] The inner surface of the housing 162 includes a housing stop member 170 and a ramp and detent portion 172, while the inner surface of the advancement wheel 164 includes a wheel stop member 165. As shown in FIG. 12, it should be appreciated that a gap exists between the housing stop member 170 and the wheel stop member 165 such that the housing stop member 170 and the wheel stop member 165 do not contact during rotation of the advancement wheel 164. However, the second wheel 166 includes a tab 168 configured to fill the gap between the housing stop member 170 and the wheel stop member 165, thereby limiting rotation of the advancement wheel 164 at a maximum forward position of the probe from the housing 162 when rotated in a forward direction, and conversely, limiting a maximum retraction of the probe into the housing 162 when rotated in a retraction direction. Additionally, the tab 168 is configured to interact with the ramp and detent portion 172 such that the tab 168 is selectively engaged by a detent of the ramp and detent portion 172 as the tab 168 moves thereover. Such engagement of the ramp and detent portion 172 with the detent provides increased tactile and / or audible feedback to the user when the probe reaches its maximum forward and / or retracted positions and also maintains the second wheel 166 in position relative to the housing stop member 170.

[0062] 11 and 12, the blood collection device 160 further includes a forward stop member 174. The forward stop member 174 is linearly movable along a slot 178 formed in the housing 162 of the blood collection device 160. The forward stop member 174 includes an interface portion 177 extending outside the housing 162, which provides a user with an interface for selectively engaging or disengaging the forward stop member 174. A protrusion 176 is provided on the top of the forward stop member 174 and protrudes into the housing 162. Also, a gap exists between the protrusion 176 of the forward stop member 174 and the wheel stop member 165 such that the protrusion 176 and the wheel stop member 165 do not contact each other during rotation of the forward wheel 164. However, the tab 168 of the second wheel 166 is configured to fill the gap between the protrusion 176 and the wheel stop member 165, thereby selectively limiting the rotation of the forward wheel 164 when the forward stop member 174 is in a particular position. For example, in the configuration shown in FIGS. 11 and 12, the advancement stop member 174 is in a first (or “disengaged”) position, with the projection 176 disposed over the tab 168 and not in contact with the tab 168 as the second wheel 166 is rotated by the advancement wheel 164. In this manner, the advancement wheel 164 is able to rotate fully, limited only by the interaction between the housing stop member 170 and the tab 168. However, a user may selectively actuate the advancement stop member 174 (via the interface portion 177 along the slot 178) such that the projection 176 is disposed within the arc of travel of the tab 168, thereby forming a physical stop for the second wheel 166 and advancement wheel 164 prior to reaching the housing stop member 170 to limit the rotation of the advancement wheel 164 and thus the linear advancement of the probe through the PIVC. Thus, a user may actuate advancement stop 174 in such a manner when the catheter of the PIVC has a shorter known length (e.g., 1.0 inch) since it limits the advancement distance of the probe beyond the distal end of housing 162. In some embodiments, advancement stop 174 is manually set by the user prior to connecting blood collection device 160 to the PIVC.

[0063] 13, a blood collection device 180 according to another embodiment of the present disclosure is shown. The blood collection device 180 includes a housing 182, an advancement wheel 184, and a second wheel 186, the advancement wheel 184 and the second wheel 186 configured to rotate about a common axis of rotation. Although not shown, the housing 182 includes a distal end and a proximal end, the distal end configured to couple to a PIVC and the proximal end configured to couple to a blood collection device. A probe (not shown) is operably coupled to the advancement wheel 184 to enable selective advancement and retraction of the probe from the housing 182. The probe (e.g., a nickel titanium wire) may be selectively advanced distally through the PIVC, the probe providing a fluid channel to enable blood collection to a blood collection device coupled to the blood collection device 180.

[0064] The inner surface of the housing 182 includes a housing stop member 190 and a ramp and detent portion 194, and the inner surface of the advancement wheel 184 includes a wheel stop member 185. As shown in FIG. 13, a gap exists between the housing stop member 190 and the wheel stop member 185 such that the housing stop member 190 and the wheel stop member 185 do not contact each other during rotation of the advancement wheel 184. However, the second wheel 186 includes a tab 187 configured to fill the gap between the housing stop member 190 and the wheel stop member 185, thereby limiting the rotation of the advancement wheel 184 at a maximum probe forward position when rotated in the forward direction, and conversely, the maximum probe retraction when rotated in the reverse direction.

[0065] The tab 187 is configured to interact with the ramp and detent portion 194 of the housing such that the tab 187 is selectively engaged by the detents of the ramp and detent portion 194 as the tab 187 moves thereover. Additionally, the tab 187 may also engage with any detents formed on the inner surface of the advancement wheel 184. In the embodiment shown in FIG. 13, the tab 187 is formed with a central slit 192 and two leg members 188A, 188B. The slit 192 allows the leg members 188A, 188B to flex individually, providing improved engagement (or "snap") to the detents of the housing 182 and / or advancement wheel 184. The thickness, size, and / or depth of the slit 192 may be adjusted to provide the best snap-fit ​​engagement of the tab 187, while still providing sufficient strength for the tab 187 to fill the gap between the housing stop member 190 and the wheel stop member 185 to form a physical stop for the advancement wheel 184.

[0066] 14, a blood collection device 200 according to another embodiment of the disclosure is shown. The blood collection device 200 includes a housing 202 and an advancement wheel 206 configured to rotate about an axis of rotation 208. The blood collection device 200 includes a distal end portion 203 and a proximal end portion, the distal end portion 203 configured to couple to a PIVC, for example, via an alligator clip connector, and the proximal end portion configured to couple to a blood collection device. A probe 204 is operably coupled to the advancement wheel 206 to enable selective advancement and retraction of the probe 204 from the housing 202. The probe 204 (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire having a fluid path and / or a sensor, etc.) can be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 200.

[0067] The blood collection device 200 may be used with PIVCs having catheters of various lengths (e.g., 1.0 inch, 1.25 inch, 1.75 inch, etc.). While the embodiments described above with respect to FIGS. 2-12 relate to blood collection devices configured to accommodate such catheter lengths by selectively limiting the rotation of the advancement wheel, the blood collection device 200 is configured such that the advancement wheel 206 can shift back and forth within the housing 202, thereby altering the possible throw distance of the probe 204 depending on the position of the advancement wheel 206. For example, when the advancement wheel 206 is in its proximal-most position within the housing 202, the distance the probe 204 can advance from the housing 202 is minimized, thereby providing a configuration useful for use with relatively short catheters (e.g., 1.0 inch). However, when the advancement wheel 206 is in its distal-most position within the housing 202, the distance the probe 204 can advance from the housing 202 is maximized, providing a configuration useful for use with longer catheters (e.g., 1.75 inch).

[0068] In some embodiments, the advancement wheel 206 is movable within the housing 202 along a substantially horizontal track 210. Although not shown, it should be understood that the advancement wheel 206 may be moved manually by any suitable means. Additionally, while Fig. 14 only illustrates the advancement wheel 206 in two positions, it should be understood that three or more different positions may be provided, with each position associated with a possible catheter length.

[0069] 15 and 16, a blood collection device 230 according to another embodiment of the present disclosure is shown. The blood collection device 230 includes a housing 232 and an advancement wheel 234 configured to rotate within the housing 232. The blood collection device 230 includes a distal end portion and a proximal end portion, the distal end portion configured to couple to a PIVC, for example, via an alligator clip connector, and the proximal end portion configured to couple to a blood collection device. A probe 235 is operably coupled to the advancement wheel 234 to enable selective advancement and retraction of the probe 235 from the housing 232. The probe 235 (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire having a fluid path and / or a sensor, etc.) may be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 230.

[0070] Blood collection device 230 may be used with PIVCs having catheters of various lengths (e.g., 1.0 inch, 1.25 inch, 1.75 inch, etc.). To accommodate such varying catheter lengths, blood collection device 230 is such that the effective path of probe 235 is alterable by selectively disposing post member 240 within vertical slot 238 of housing 232. Interface member 242 may be provided on an exterior surface of housing 232 to allow user manipulation of post member 240.

[0071] 15 and 16, with post member 240 in its uppermost position, probe 235 moves over post member 240 to shorten the effective length of probe 235, thereby shortening the distance probe 235 can advance from housing 232. This configuration is useful for use with relatively short catheters (e.g., 1.0 inch). However, as post member 240 moves downward along slot 238, the effective length of probe 235 increases, and therefore the distance probe 235 can advance from housing 232 increases. Such an alternative configuration is useful for use with longer catheters (e.g., 1.5 inch, 1.75 inch, etc.).

[0072] 17 and 20, a blood collection device 250 according to another embodiment of the disclosure is shown. The blood collection device 250 includes a housing 252 and an advancement wheel 254 configured to rotate within the housing 252. The blood collection device 250 includes a distal end portion and a proximal end portion, the distal end portion configured to couple to a PIVC, e.g., via an alligator clip connector, and the proximal end portion configured to couple to a blood collection device. A probe 258 is operably coupled to the advancement wheel 254 to enable selective advancement and retraction of the probe 258 from the housing 252. The probe 258 (e.g., a nickel titanium wire, a guidewire, an instrument, an occluder, a rod, a wire having a fluid path and / or a sensor, etc.) may be selectively advanced distally through the PIVC to provide a fluid channel for enabling blood collection to a blood collection device coupled to the blood collection device 250.

[0073] The blood collection device 250 may be used with PIVCs having catheters of various lengths (e.g., 1.0 inch, 1.25 inch, 1.5 inch, 1.75 inch, etc.). To accommodate such varying catheter lengths, the blood collection device 250 includes a spool 257 having a probe anchor 260, around which a probe 258 is wound to selectively shorten or lengthen the effective length of the probe 258. More specifically, the blood collection device 250 includes a rotatable knob 256 accessible to a user from outside the housing 252, the knob 256 configured to selectively position a spool stop member 264 that protrudes into the interior of the housing 252 based on a known catheter length. For example, as shown in FIG. 17, the knob 256 may be positioned in one of four positions for possible catheter lengths of 1.0 inch, 1.25 inch, 1.5 inch, and 1.75 inch, respectively. However, it should be understood that more or fewer catheter lengths and knob positions are possible and within the scope of the present disclosure.

[0074] Based on the user-selected position of knob 256, spool stop member 264 is positioned relative to stationary housing stop member 262 such that spool stop member 264 is configured to contact housing stop member 262 as probe 258 unwinds from spool 257. For example, with reference to FIG. 18 , spool stop member 264 is positioned directly adjacent housing stop member 262, thereby preventing further rotation of spool 257 once probe 258 has been advanced to maximum extension by advancement wheel 254. This position of spool stop member 264 correlates the user-selected position of knob 256 with a minimum catheter length setting (e.g., 1.0 inch), thereby limiting advancement of probe 258 from housing 252. However, when the user rotates knob 256 to a longer catheter length setting (e.g., 1.75 inches, as shown in FIG. 19), spool stop member 264 is positioned away from housing stop member 262, thereby allowing further rotation of spool 257 and thus further advancement of probe 258 to accommodate the longer catheter, as shown in FIG. 20.

[0075] While some embodiments above detail advancement of the distal tip of the probe slightly beyond the distal tip of the catheter, in other embodiments the blood sampling device is configured such that the distal tip of the probe does not extend beyond the distal tip of the catheter and therefore does not extend outside the catheter tube.

[0076] Although several embodiments of a fluid transfer device configured for blood sampling during catheterization have been described in the foregoing detailed description, those skilled in the art may make modifications and variations to these embodiments without departing from the scope and spirit of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The present invention as described above is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. 1. A blood sampling device for delivering a probe to a patient's vascular system, comprising: a housing having a proximal end and a distal end; an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel; a forward motion stop member positionable by a user via an interface portion exterior to the housing and configured to selectively limit rotation of the forward motion wheel; A blood collection device comprising:

2. The blood collection device of claim 1 , further comprising a second wheel, said second wheel configured to rotate with said advancement wheel about a common axis of rotation.

3. The blood collection device of claim 2 , wherein the housing further comprises a housing stop, the advancement wheel includes a wheel stop, and the second wheel includes a tab.

4. The blood collection device of claim 3 , wherein the tab of the second wheel is configured to selectively fill a gap between the housing stop member and the wheel stop member.

5. The blood collection device of claim 3 , wherein the advancement stop member includes a protrusion, and the tab of the second wheel is configured to selectively fill a gap between the protrusion and the wheel stop member.

6. The blood collection device of claim 5 , wherein the advancement stop member is movable within a slot formed in the housing to selectively position the protrusion against the tab of the second wheel.

7. The blood collection device of claim 6 , wherein the slot is a vertical slot formed in the housing.

8. The blood collection device of claim 6 , wherein the slot is an arcuate slot formed in the housing.

9. The blood collection device of claim 6 , wherein the housing includes indicia adjacent the slot, the indicia relating to various catheter lengths of intravenous catheters usable with the blood collection device.

10. The blood collection device of claim 5 , wherein the advancement stop member is selectively movable within the housing via a push button interface.

11. The blood collection device of claim 5 , wherein the advancement stop member is selectively insertable and removable from the housing.

12. The blood collection device of claim 3 , wherein the housing further comprises a ramp and detent portion adjacent the housing stop member.

13. The blood collection device of claim 3 , wherein the tab includes a central slit.

14. 1. A blood sampling device for delivering a probe to a patient's vascular system, comprising: a housing having a proximal end and a distal end; an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel; an advancement wheel selectively positionable within the housing to vary an effective length of the probe based on a position of the advancement wheel.

15. The blood collection device of claim 14 , wherein the axle of the advancement wheel is configured to move within a longitudinal slot formed in the housing.

16. 15. The blood collection device of claim 14, wherein the advancement wheel is positionable between at least a first position and a second position, the first position associated with a first catheter length of an intravenous catheter usable with the blood collection device, and the second position associated with a second catheter length of an intravenous catheter usable with the blood collection device.

17. 1. A blood sampling device for delivering a probe to a patient's vascular system, comprising: a housing having a proximal end and a distal end; an advancement wheel operatively coupled to the probe for advancing and retracting the probe based on a direction of rotation of the advancement wheel; a rotatable spool configured to hold at least a portion of the probe, the rotatable spool including a probe anchor, and an amount of rotation of the rotatable spool is selectively limited to vary an effective length of the probe based on the amount of rotation of the rotatable spool; A blood collection device comprising:

18. 20. The blood collection device of claim 17, further comprising a rotatable knob accessible to a user from outside the housing.

19. The blood collection device of claim 18 , wherein the rotatable knob is operably coupled to a spool stop member extending into the housing.

20. 20. The blood collection device of claim 19, further comprising a housing stop configured to contact the housing stop to limit rotation of the rotatable spool and adjust the effective length of the probe.

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